south african medical technology industry association
advancing innovation responsibility
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Welcome,
ESTABLISHED in 1985, SAMED is recognised as an important player in the South African healthcare industry.

The association, which promotes, represents and safeguards the interests of the South African Medical Device and In-Vitro Diagnostics (IVD) industry, focuses on healthcare matters relevant to its members' interests.

These include providing proactive representation to relevant and appropriate stakeholders as well as encouraging ethical principles and practices within the sector.
Medical technology enable people to live healthy and productive lives
Our Industry's innovations improve people's lives
We support safe, harmonized and sustainable medical technology legislation
We are committed to encouraging ethical principles and practices
We are committed to ensuring a sustainable medical technology industry in South Africa
SAMED represents the medical technology industry in South Africa
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BSI Group South Africa






The best route to getting your products to market

As a client of BSI you will have confidence knowing that we conduct robust, comprehensive assessments that will stand up to scrutiny.  We are well-known worldwide for our fast, efficient and predictable service, meaning you will know what to expect with timely results and no surprises.  This creates the best route to market for you.

ISO 13485 Quality Management Certification

ISO 13485 is an international standard recognized for medical device QMS registration. It helps manufacturers consistently manufacture devices that are safe and fit for their intended purpose and meet regulatory requirements.

ISO 13485 Training

  1. South African Medical Device Legislation (SAMDL)
  2. ISO 13485: Requirements
  3. ISO 13485: Clause by Clause
  4. ISO 13485: Implementation
  5. ISO 13485: Internal Auditor
  6. ISO 13485: Lead Auditor

For more info, please contact bsi.za@bsigroup.com